Freelance Clinical Research Associate

Location
Sweden (SE)
Salary
Competitive hourly rate
Posted
16 Aug 2019
Closes
15 Sep 2019
Ref
CRA-SWEDEN
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality. We have positioned ourselves right in the middle of the action, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.

Working at Premier Research means being an individual - you will be recognized for what you do and you will truly have an impact. You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority.

Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it! 


We’re looking for a CRA II or Senior CRA to join our team on a freelance basis! This will be initially a 6 month Contract and we require 0.5 FTE. You will need to speak Swedish, Danish and English. This will be a home based role in Sweden or Denmark.

Imagine. Inspire. Innovate. Impact. With Us.

You’ll be accountable for:
 

  • Delivering high-quality, timely monitoring reports for sponsor approval per Clinical Monitoring Plan timelines.
  • Scheduling site visits for monitoring as required by protocol monitoring visit windows.
  • Ensuring the validity, correctness, and completeness of clinical data reviewed and collected at assigned sites as dictated by trial protocol, ICH-GCP/ISO 141155, and customer requirements.
  • Monitoring data — remotely, on site, and via other approved modes — with a focus on data integrity and patient safety, in accordance with specific country regulations.
  • Preparing for and conducting qualification, study initiation, interim monitoring, and close-out visits at investigator sites.
  • Managing query resolution with study sites and Premier Research data management operations.
  • Maintaining the project tracking system of subjects and site information.
  • Participating in Investigators’ Meetings as assigned by Project Managers.
  • Ensuring adherence to study timelines and budgets.
  • Identifying and escalating potential risks and identifying retraining opportunities for site study teams.
  • Mentoring junior-level staff and sharing knowledge and best practices.
  • Participating in training offered to increase therapeutic knowledge and keeping current with regulations and FDA guidance.
  • In specific countries or situations, assuming country-specific responsibilities and/or being named a subject-matter expert in one or more areas; e.g.: start-up, regulatory, site contracts, office management.
  • Assuming additional duties on certain projects, such as clinical management for smaller or less complex studies.

You'll need this to be considered:

  • Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required.
  • Prior experience in monitoring of pharma trials is required
  • Working knowledge of FDA Guidance Documents / EU Directives / local regulations / ISO14155 regulations, drug / device development, and clinical monitoring procedures
  • Ability to multitask and work effectively in a fast-paced environment with changing priorities
  • Strong verbal and written communication skills
  • Fluency in written and verbal English, Swedish and Danish is mandatory.
  • Excellent organizational and time-management skills, able to meet deadlines
  • Accountable, dependable and strong commitment
  • Customer service focused in approach to work, both internally and externally
  • Maintains a positive, results orientated work environment
  • Travel: 70%
  • Available to start immediately at 0.5 FTE

Apply for Freelance Clinical Research Associate

Already uploaded your CV? Sign in to apply instantly

Apply

Upload from your computer

Or import from cloud storage

Your CV must be a .doc, .pdf, .docx, .rtf, and no bigger than 1MB


4000 characters left

Marketing Communication

We'd love to send you information about Jobs and Services from PharmiWeb.jobs by email.

All emails will contain a link in the footer to enable you to unsubscribe at any time.


When you apply for a job we will send your application to the named recruiter, who may contact you. By applying for a job listed on PharmiWeb.jobs you agree to our terms and conditions and privacy policy. You should never be required to provide bank account details. If you are, please email us.

Similar jobs

Similar jobs